Does your study require ethics review?

  1. Resources for guidelines.
  2. Research requiring ethics review
  3. Research not requiring ethics review
  4. Case studies/reports
  5. Research vs. quality assurance and checklist
  6. Student research
  7. Health research
  8. Clinical Trials
  9. Secondary Use of Data/Biological Materials

1. Resources

Requirements for ethical review and approval of research involving humans are in compliance with the following guidelines:
  1. Tri- Council Policy Statement on Research involving Human Subjects (TCPS2) Section A. Research Requiring REB Review; Article 2.1
  2. Good Clinical Practice: Consolidated Guideline; ICH Topic E6 Article 4.4 Communication with IRB/IEC/REB (Research Ethics Board, REB)
If, after reading the following information, you have questions regarding the status of your project please contact the HREB office to get direction. Retroactive approval for studies initiated before review and approval is never granted.

The following information is adapted from these guidelines

 2. Research requiring ethics review and approval before the research begins

  1. Research involving living human participants (human participants are those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question).
  2. Research involving human biological materials (including remains, cadavers, tissues, biological fluids, embryos, fetuses, fetal tissue, reproductive materials and stem cells).
  3. Research about individuals in the public arena if s/he is to be interviewed and/or private papers (personal letters or journals) accessed.
  4. Research involving secondary use of data (use of data initially collected for another purpose) -  health records, employee records, student records, computer listings, banked tissue, data collected for a different research project, if any form of identifier is involved and/or if data linkage or results could generate identifiable information. 
  5. Quality assurance studies and program evaluations which address a research question.
  6. The collection of data or biological materials for the storage for future research purposes (in or outside the province); even if it is a biobank/repository located outside the province and one sample is being sent for storage.

3. Research not requiring ethics review

The following are examples of activities that do not require review by a research ethics board (REB). These may, nevertheless, raise ethical issues that would benefit from careful consideration outside of the REB.

  1. Research that relies exclusively on publicly available information when the information is legally accessible to the public and appropriately protected by law; or the information is publicly accessible and there is no reasonable expectation of privacy. 
  2. Research involving naturalistic observation in public places (where it does not involve any intervention staged by the researcher, or direct interaction with the individual or groups; individuals or groups targeted for observation have no reasonable expectation of privacy; and any dissemination of research results does not allow identification of specific individuals).
  3. Quality assurance and quality improvement studies, program evaluation activities, performance reviews, and testing within normal educational requirements if there is no research question involved (used exclusively for assessment, management or improvement purposes).
  4. Research based on review of published/publicly reported literature.
  5. Research exclusively involving secondary use of anonymous information or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information.  
  6. Research based solely on the researcher’s personal reflections and self-observation (e.g. auto-ethnography).
  7. Case reports.
  8. Creative practice activities (where an artist makes or interprets a work or works of art).

4. Case Studies/Reports

Case reports are normally based on the clinical notes of an individual patient/client with the informed consent and do not require research ethics review.

Case studies may be based on documents concerning individuals with or without information collected through personal contact.  Such studies require the individual consent of the subjects of the study and normally require research ethics review. Investigator should contact the HREB if in doubt.

5. Quality Assurance vs. Research

Q: Is your study program evaluation (which does not require ethics review) or research?

A:   If the intent is internal use for assessment, management or improvement purposes, then it is program evaluation; if the intent is generalizable knowledge (e.g., examining your processes as a case for the purpose of extending knowledge to other similar programs),  then it is research.
The following may be present in program evaluation as well as in research and are not useful for determining whether your project requires REB review:
• Intent to publish.   Both research and program evaluation can be published.  Intent to publish does not mean that your project requires REB review. 
• Use of rigorous methods of data collection and data analysis.  Program  evaluation  may share some methods and techniques with those employed in research (such as data collection and data analysis)
BE STRATEGIC with the words you use to describe your project as your wording will influence whether an REB or a publisher assumes it is research or program evaluation.  For example, if it is program evaluation, call it that (or refer to it as a “project” or a “program”); do not refer to it as “research”.   Pay attention to how you describe your objectives and rationale or purpose.  Words or phrases that imply that other similar programs will benefit from your study imply that you are doing research, not program evaluation.
NO approval ‘after the fact’ can be done.  If a project is done for program evaluation and then it is later decided to use the information for research, then this would be secondary use of data and the REB process for secondary use of data should be followed.
Program evaluations involving MUN programs may require a privacy impact assessment through the university’s privacy office.
Still need help?
•The HREA website contains a tool created by The Alberta Research Ethics Community Consensus Initiative (ARECCI)   to help determine whether an activity is research or quality assurance
•TCPS 2 , Article 2.1 (definition of research) and Article  2.5 (exemptions from research)
•TCPS 2 interpretations posted by the Panel on Research Ethics (items 2 and 7)
•If you are still in doubt about whether your study is program evaluation (which does not require REB review) or research (which does require REB review) please email the Ethics Office ( and inquire. Your email should include a summary of the project objectives, method, and purpose.   

Some data collection and analysis in investigations in the health area are not intended to generate scientific knowledge. They are activities used to improve the provision of services or programs to a specific population. The results of the data collection and analysis may be published. These activities are generally referred to as program evaluation or quality assurance/improvement. Investigations of this kind should be approved by the relevant program/institution involved but do not require research ethics review. The following checklist is intended to help the researcher determine whether a study is research or quality assurance/quality improvement/program evaluation.


Project Primary Purpose: Screening Tool for Determining the Appropriate Route for Ethics Review

This checklist is intended to be used as a pragmatic screening tool to help sort projects by primary purpose to determine the appropriate route for ethics review. That is, is the project research? If so, it should be submitted to an REB. Is the project quality or evaluation? If so, proceed with locally relevant policies for review of quality or evaluation projects. The recommended ethics review process depends on a number of factors (including local policies, level of risk, etc.) and may require further exploration on a project specific basis. This tool has not been validated and is not intended to replace professional judgment and interpretation, but was developed to help increase consistency and transparency of ethics screening processes.

  Question Yes No
1 Is the project funded by, or being submitted to, a research funding agency  for a research grant or award that requires research ethics review  
2 Are there any local policies which require this project to undergo review by a Research Ethics Board?  
  IF YES to either of the above, the project should be submitted to a Research Ethics Board.
IF NO to both questions, continue to complete the checklist.
3 Is the primary purpose of the project to contribute to the growing body of knowledge regarding health and/or health systems that are generally accessible through academic literature?  
4 Is the project designed to answer a specific research question or to test an explicit hypothesis?  
5 Does the project involve a comparison of multiple sites, control sites, and/or control groups?  
6 Is the project design and methodology adequate to support generalizations that go beyond the particular population the sample is being drawn from?  
7 Does the project impose any additional burdens on participants beyond what would be expected through a typically expected course of care or role expectations?  
  LINE A: SUBTOTAL Questions 3 through 7 = (Count the # of Yes responses)    
8 Are many of the participants in the project also likely to be among those who might potentially benefit from the result of the project as it proceeds?  
9 Is the project intended to define a best practice within your organization or practice?  
10 Would the project still be done at your site, even if there were no opportunity to publish the results or if the results might not be applicable anywhere else?  
11 Does the statement of purpose of the project refer explicitly to the features of a particular program,
Organization, or region, rather than using more general terminology such as rural vs. urban populations?
12 Is the current project part of a continuous process of gathering or monitoring data within an organization?    
  LINE B: SUBTOTAL Questions 8 through 12 = (Count the # of Yes responses)    

  • If the sum of Line A is greater than Line B, the most probable purpose is research. The project should be submitted to an REB.
  • If the sum of Line B is greater than Line A, the most probable purpose is quality/evaluation. Proceed with locally relevant process for ethics review (may not necessarily involve an REB).
  • If the sums are equal, seek a second opinion to further explore whether the project should be classified as Research or as Quality and Evaluation.
*Source of ARECCI Recommendations: Protecting People While Increasing Knowledge: Recommendations for a Province wide Approach to Ethics Review of Knowledge Generating Projects (Research, Program Evaluation, and Quality Improvement) in Health Care [December 2005), Alberta Research Ethics Community Consensus Initiative (ARECCI). For more information visit the ARECCI website at

6. Student Research

The requirements for ethics review of the research studies of undergraduate, graduate and postgraduate students and the level of scrutiny are the same as those applying to non-student researchers. 

A.     Student applications:
  • All students are expected to complete all documentation required for review and discuss with their instructor or supervisor the completed application which must be signed by both the student and faculty member.  In cases where a graduate student is working on a component of a much larger piece of research, it is expected that the student will clearly delineate the boundaries of his/her project and state the objectives specific to their thesis project.   
  • Graduate students are expected to submit their applications as the principal investigator for their thesis research.  As the primary investigator they and their supervisor would be held accountable for any breach of research ethics.
B.    Studies that are part of undergraduate course requirements:

 In some cases the HREB may approve simple research exercises included as a requirement in an undergraduate course (e.g., short doorstep interviews with persons from four randomly selected households) along with accompanying course material instructing the students in the relevant ethical issues.  This approval is renewed year to year and eliminates the necessity for each student group to submit individual applications. The course professor submits a letter of request, describing the course and providing course materials, and acts as the contact person for all interactions with the REB.

Type of review: Student research is regarded as a means of acquiring research skills.  It is assumed that most undergraduate studies will be of minimal risk (see Chapter 2 B in TCPS2)  and applications will receive delegated review.  However, any student project deemed by the HREB to be of greater than minimal risk will be sent for review by the full committee.  

7. Health Research

Is your research HEALTH research?
HREA Act, section 2(d) “health research involving human subjects” means activities whose primary goal is to generate knowledge in relation to human health, health care and health care systems, and involving human beings as research subjects, health care information respecting human beings or human biological material.

This includes all research related to health education (e.g. curriculum development in nursing or medicine).  Health research does not include tests on non-healthcare equipment or tools to be used by humans, even where the research methods may put humans at risk (e.g. automobile or helicopter safety studies, research to study early childhood learning patterns, human kinetic research to establish parameters of safety for sports equipment).

To note: health research being conducted where the researcher is not affiliated with MUN and participants or data are not about Newfoundland and Labrador or its population does not require local ethics review.

In addition, national health surveys being conducted where the researcher is not affiliated with MUN that include Newfoundlanders and Labradoreans as participants, but do not identify Newfoundland and Labrador as an aggregate and do not report findings specific to Newfoundland and Labrador or to aggregates within Newfoundland and Labrador, does not require local ethics review.   

8. Clinical Trials

Is your health research a clinical trial?
A clinical trial is ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

Interventions include but are not restricted to drugs, radiopharmaceuticals, cells and other biological products, surgical procedures, radiological procedures, devices, genetic therapies, natural health products, behavioral treatments, process-of-care changes, preventive care, manual therapies and psychotherapies. 

9. Secondary Use of Data/Biological Materials

Secondary use of data/biological materials refers to both:

  • Accessing data/samples that was collected for a different purpose to answer a research question (e.g. research using medical charts); and
  • Re-analyzing an existing research data set with a different research question.

Both types of secondary use requires ethics review.